INSPIRE Trial for Abdominal Infections

NCT05423743 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198480

Last updated 2025-08-15

Study results available
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Summary

The INSPIRE Abdominal Infection Trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (CPOE) smart prompts providing the probability that a non-critically ill adult admitted with abdominal infection is infected with a resistant pathogen.

Note: enrolled "subjects" represent 102 individual HCA Healthcare hospitals that have been randomized into 92 clusters. Hospitals were grouped into the same randomization cluster if they shared campuses or antibiotic stewardship staff.

Conditions

  • Abdominal (ABD) Infection

Interventions

OTHER

Arm 1: Routine Care

Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.

OTHER

Arm 2: INSPIRE Stewardship Bundle for Abdominal Infection

Quality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having an abdominal infection due to a multidrug-resistant organism (MDRO) and recommends standard spectrum antibiotics for low risk patients in the first 3 days of hospitalization; (2) clinician feedback reports, and (3) activities to support CPOE adoption (including education and alignment of CPOE workflows). Other antibiotic stewardship activities to continue in accordance with national standards.

Sponsors & Collaborators

  • Hospital Corporation of America

    collaborator INDUSTRY
  • University of California, Irvine

    collaborator OTHER
  • University of Massachusetts, Amherst

    collaborator OTHER
  • Brigham and Women's Hospital

    collaborator OTHER
  • Rush University

    collaborator OTHER
  • Harvard Pilgrim Health Care

    lead OTHER

Principal Investigators

  • Shruti Gohil, MD, MPH · UC Irvine Division of Infectious Diseases

  • Susan Huang, MD, MPH · UC Irvine Division of Infectious Diseases

  • Richard Platt, MD, MS · Harvard Pilgrim Health Care Institute/Harvard Medical School

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-05-09
Completion
2025-05-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05423743 on ClinicalTrials.gov